AQUABPLUS, B2, HF 2000 KIT

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT AN AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM POWERED DOWN BY ITSELF IN STAGE 1. INITIALLY, THE MOTOR PROTECTION SWITCH (MPS) TURNED OFF (THE RED BUTTON POPPED OUT). THE BIOMED TRIED PRESSING THE GREEN BUTTON TO TURN IT BACK ON, BUT THE SCREEN WOULD FLASH AND THEN THE RED BUTTON WOULD POP BACK OUT. EVENTUALLY THE RED BUTTON WAS NO LONGER POPPING OUT WHEN THE BIOMED PRESSED THE GREEN BUTTON. WHEN THEY PRESSED THE RED BUTTON, THE SCREEN FLASHED BUT THE RED BUTTON STAYED PUSHED IN. THE BIOMED MENTIONED THAT THE BLACK WIRE ON THE BACK OF THE MPS LOOKED BURNT. THE BIOMED SAID THEY CHANGED THE MPS AND THE RO RUNS FINE NOW. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE BIOMED CONFIRMED FINDING A BURNT BLACK WIRE ON THE BACK OF THE MPS. THE MACHINE WAS IN SUPPLY MODE WHEN THE FAILURE OCCURRED, BUT NO TREATMENTS WERE DIRECTLY IMPACTED. THE BIOMED STATED THAT THE TREATMENTS WERE ABLE TO BE CONTINUED WITHOUT INTERRUPTION, AND THE RO WAS ONLY DOWN FOR APPROXIMATELY SEVEN MINUTES. THE BIOMED SAID THE RO POWERED DOWN BY ITSELF IN STAGE 1. THERE WERE NO ALARM CODES DISPLAYED WHEN THE FAILURE OCCURRED. THE BIOMED ALSO CONFIRMED THE THERMAL OVERLOAD SWITCH WAS NOT TRIPPING. IT WAS JUST THE ON/OFF SWITCH THAT WAS FAILING. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY, AND THE BIOMED CONFIRMED THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE TIME OF THE EVENT. THE BIOMED WAS ABLE TO RESOLVE THE ISSUE BY REPLACING THE MPS. THE BIOMED WAS ALSO SENT A NEW POWER CABLE WHICH THEY PLANNED TO REPLACE THE NEXT TIME THEY WERE ONSITE. THE BIOMED SAID THE REPLACEMENT POWER CABLE INCLUDES THE L1, L2, AND L3 POWER LUGS. THE BIOMED ALSO CONFIRMED THAT THE BURNT BLACK CABLE WAS PART OF THE CABLE BUNDLE AND WOULD BE REPLACED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE AQUABPLUS WAS FULLY OPERATIONAL AND HAS NOT EXPERIENCED ANY FURTHER ISSUES. THE FTP FILES WERE NOT READILY AVAILABLE AS THEY WERE NOT DOWNLOADED. TWO PHOTOS OF THE MPS AND CONNECTED CABLES WERE PROVIDED FOR REVIEW.

Additional Manufacturer Narrative

PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE FAILURE PATTERN IS A KNOWN ISSUE AND IS ADDRESSED IN A CAPA. THE REPORTED THERMAL DAMAGE FOUND AT THE MOTOR PROTECTION SWITCH (MPS) WAS ABLE TO BE CONFIRMED BY REVIEWING THE PROVIDED PHOTOS. BAD ELECTRICAL CONTACT AND INCREASED CONTACT RESISTANCE AT THE MPS IS THE LIKELY CAUSE OF THE THERMAL DAMAGE. THE CABLE LUGS AT THE MPS WOULD OVERHEAT AND BECOME DISCOLORED BY THE RELEASED THERMAL ENERGY AT THE BAD ELECTRICAL CONTACT POINT. AS A RESULT, THE THERMAL OVERLOAD SWITCH OR MPS COULD TRIP, INTERRUPTING THE OPERATION OF THE DEVICE. IN THIS CASE, IT WAS THE MPS THAT TRIPPED. AS A CORRECTIVE ACTION FROM THIS KNOWN ISSUE, A NEW WIRING DESIGN WAS RELEASED. HOWEVER, THIS DEVICE WAS BUILT BEFORE IMPLEMENTATION OF THE NEW DESIGN. A REVIEW OF THE MACHINE FILES WAS NOT REQUIRED. ADDITIONALLY, NO REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS REQUIRED. BASED ON THE INFORMATION AVAILABLE AND THE PROVIDED PHOTOS, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT AN AQUABPLUS REVERSE OSMOSIS (RO) SYSTEM POWERED DOWN BY ITSELF IN STAGE 1. INITIALLY, THE MOTOR PROTECTION SWITCH (MPS) TURNED OFF (THE RED BUTTON POPPED OUT). THE BIOMED TRIED PRESSING THE GREEN BUTTON TO TURN IT BACK ON, BUT THE SCREEN WOULD FLASH AND THEN THE RED BUTTON WOULD POP BACK OUT. EVENTUALLY THE RED BUTTON WAS NO LONGER POPPING OUT WHEN THE BIOMED PRESSED THE GREEN BUTTON. WHEN THEY PRESSED THE RED BUTTON, THE SCREEN FLASHED BUT THE RED BUTTON STAYED PUSHED IN. THE BIOMED MENTIONED THAT THE BLACK WIRE ON THE BACK OF THE MPS LOOKED BURNT. THE BIOMED SAID THEY CHANGED THE MPS AND THE RO RUNS FINE NOW. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE BIOMED CONFIRMED FINDING A BURNT BLACK WIRE ON THE BACK OF THE MPS. THE MACHINE WAS IN SUPPLY MODE WHEN THE FAILURE OCCURRED, BUT NO TREATMENTS WERE DIRECTLY IMPACTED. THE BIOMED STATED THAT THE TREATMENTS WERE ABLE TO BE CONTINUED WITHOUT INTERRUPTION, AND THE RO WAS ONLY DOWN FOR APPROXIMATELY SEVEN MINUTES. THE BIOMED SAID THE RO POWERED DOWN BY ITSELF IN STAGE 1. THERE WERE NO ALARM CODES DISPLAYED WHEN THE FAILURE OCCURRED. THE BIOMED ALSO CONFIRMED THE THERMAL OVERLOAD SWITCH WAS NOT TRIPPING. IT WAS JUST THE ON/OFF SWITCH THAT WAS FAILING. THERE WERE NO BLOWN FUSES IN THE LOCAL POWER SUPPLY, AND THE BIOMED CONFIRMED THERE WERE NO LOCAL POWER GRID ISSUES AROUND THE TIME OF THE EVENT. THE BIOMED WAS ABLE TO RESOLVE THE ISSUE BY REPLACING THE MPS. THE BIOMED WAS ALSO SENT A NEW POWER CABLE WHICH THEY PLANNED TO REPLACE THE NEXT TIME THEY WERE ONSITE. THE BIOMED SAID THE REPLACEMENT POWER CABLE INCLUDES THE L1, L2, AND L3 POWER LUGS. THE BIOMED ALSO CONFIRMED THAT THE BURNT BLACK CABLE WAS PART OF THE CABLE BUNDLE AND WOULD BE REPLACED. THE SAMPLE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. IT WAS CONFIRMED THAT THE AQUABPLUS WAS FULLY OPERATIONAL AND HAS NOT EXPERIENCED ANY FURTHER ISSUES. THE FTP FILES WERE NOT READILY AVAILABLE AS THEY WERE NOT DOWNLOADED. TWO PHOTOS OF THE MPS AND CONNECTED CABLES WERE PROVIDED FOR REVIEW.